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Engaging Caregivers in Dementia Care

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ClinicalTrials.gov Identifier: NCT02552563
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Shahrzad Mavandadi, Corporal Michael J. Crescenz VA Medical Center

Tracking Information
First Submitted Date  ICMJE September 4, 2015
First Posted Date  ICMJE September 17, 2015
Last Update Posted Date September 28, 2022
Study Start Date  ICMJE February 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
  • Revised Memory and Behavior Problems Checklist (RMBPC) [ Time Frame: Change in frequency and distress from baseline to 3 and 6 month follow-up ]
    Frequency of care recipient dementia-related behaviors and associated caregiver distress
  • Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: Change in frequency and distress from baseline to 3 and 6 month follow-up ]
    Frequency of care recipient neuropsychiatric symptoms and associated caregiver distress
  • Zarit Burden Interview [ Time Frame: Change in burden from baseline to 3 and 6 month follow-up ]
    Perceived caregiver burden
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2015)
  • Pearlin Stress and Coping Scale [ Time Frame: Change in coping skills from baseline to 3 and 6 month follow-up ]
    Caregiver coping strategies
  • Lawton Caregiving and Stress Process Scales [ Time Frame: Change in caregiver mastery from baseine to 3 and 6 month follow-up ]
    Caregiver mastery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Engaging Caregivers in Dementia Care
Official Title  ICMJE Engaging Caregivers in the Care of Veterans With Dementia
Brief Summary This pilot study seeks to examine the extent to which, relative to usual care, a dementia care management program for veterans and their caregivers (CGs)improves patient (e.g., behavioral symptoms, delayed nursing home placement) and caregiver (e.g., CG mastery, burden, affect) outcomes.
Detailed Description Dementia care guidelines and pharmacological and non-pharmacological treatments have been shown to reduce symptom burden and rates of institutionalization for individuals with dementia. However, there remain a variety of factors that complicate dementia care management in primary care settings. Patient-centered, integrated care management programs that involve caregiver (CG) education and psychosocial support may help facilitate access to and use of services and improve outcomes. The aims of this pilot were to examine 1) whether, relative to usual care (UC), a dementia care management program is associated with improved CG (e.g., mastery, burden, affect) and patient (e.g., behavioral symptoms) outcomes, 2) if, relative to UC, participants enrolled in the program have greater perceived access to and use of medical, social, and community/VA services, and 3) whether the dementia care management program is feasible and acceptable to participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Dementia
Intervention  ICMJE Behavioral: Dementia Care Management
The intervention involves two main components. The first component includes individualized dementia care management that involves regular and extended contact between the CG, care manager, and when appropriate, Veteran's primary care provider (PCP). The care manager monitors Veterans' symptoms via CG report, provides psychoeducation and support to CGs, influences adherence to guidelines by providing timely and tailored information to PCPs, and suggests appropriate care strategies and service referrals. The second major component is the Telehealth Education Program (TEP). For this pilot study, the program was modified for use with individual CGs and was formatted so that CGs could select from a menu of up to 7 modules covering various content areas evaluated during the course of the care management assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, long-term planning, etc.).
Other Name: Telehealth Education Program
Study Arms  ICMJE
  • No Intervention: Usual Care
    Standard care received by veterans in the Corporal Michael J. Crescenz VA Medical Center
  • Active Comparator: Dementia Care Management
    CG education, continuous support, communication and coping skills training, and veteran monitoring, via CG report, of medication, symptoms, and service needs.
    Intervention: Behavioral: Dementia Care Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2015)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient and caregiver 18 years of age or older
  • Patient is community dwelling
  • Patient has a confirmed dementia diagnosis and/or significant cognitive impairment (per provider or CG report) that is verified upon the RA's cognitive screening assessment (per veteran (BOMC, score of 16 or above) or informant (AD8, score of 2 or above) and/or chart review
  • CG lives with and/or provides care for the patient for an average of at least 4 hours per day.
  • Veteran provides assent to contact his/her representative to pursue study participation
  • Veteran representative as caregiver is willing and able to provide informed consent

Exclusion Criteria:

  • Cognitive, hearing, visual, or other physical impairments leading to difficulty with assent/ informed consent process and/or assessment (veteran or caregiver)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02552563
Other Study ID Numbers  ICMJE 01247
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shahrzad Mavandadi, Corporal Michael J. Crescenz VA Medical Center
Original Responsible Party Corporal Michael J. Crescenz VA Medical Center
Current Study Sponsor  ICMJE Corporal Michael J. Crescenz VA Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shahrzad Mavandadi, PhD Corporal Michael J. Crescenz VA Medical Center
PRS Account Corporal Michael J. Crescenz VA Medical Center
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP